18:23 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

FDA approves CV label update for Pfizer's Celebrex

FDA approved a label supplement for Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) to include data from a postmarketing cardiovascular outcomes trial showing that the lowest approved dose of Celebrex had similar CV safety to that...
15:20 , May 9, 2018 |  BC Innovations  |  Distillery Therapeutics

Musculoskeletal

INDICATION: Muscular dystrophy Mouse studies suggest that COX-2 inhibition could help treat Duchenne muscular dystrophy (DMD). In a mouse model of DMD, the COX-2 inhibitor Celebrex celecoxib decreased immune cell infiltration in tibialis anterior muscle and...
19:56 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

FDA panel affirms safety of Pfizer's Celebrex

FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that the Phase IV CV outcomes PRECISION trial showed that Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) had comparable cardiovascular safety to...
20:48 , Apr 25, 2018 |  BC Extra  |  Company News

FDA panel affirms safety of Pfizer's Celebrex

FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that the Phase IV CV outcomes PRECISION trial showed that Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) had comparable cardiovascular safety to...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
18:21 , Apr 3, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Epilepsy Mouse studies suggest inhibiting COX-2 could help treat autosomal dominant lateral temporal lobe epilepsy (ADLTE), which is caused by LGI1 mutations. In cortex samples from a LGI1-knockout mouse model of ADLTE, levels of COX-2...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...
22:50 , Jan 5, 2018 |  BioCentury  |  Emerging Company Profile

Against radical pain

CerSci Therapeutics thinks that by neutralizing peroxynitrite and other free radicals it can treat acute pain and prevent it from becoming chronic, without the potential for abuse and addiction. CerSci was founded in 2014 to create...
23:20 , Nov 30, 2017 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Kitov's KIT-302 to treat OA pain and hypertension

FDA accepted for review an NDA from Kitov Pharmaceuticals Holdings Ltd. (Tel Aviv:KTOV; NASDAQ:KTOV) for celecoxib/amlodipine besylate (KIT-302) to treat pain associated with osteoarthritis and hypertension simultaneously. The PDUFA date is May 31. The candidate is...
16:26 , Mar 17, 2017 |  BC Week In Review  |  Company News

Kitov, Kuhnil deal

Kitov granted Kuhnil exclusive South Korean rights to develop and commercialize KIT-302. Kitov is eligible for undisclosed regulatory milestones and double-digit royalties. Kuhnil will be responsible for obtaining regulatory approval in South Korea and expects...